Utrecht Startup Guideways Raises Funding To Speed Up Medtech Approvals

Utrecht-based AI startup Guideways, which assists medtech companies with complex regulatory and compliance challenges, has raised pre-seed funding from Healthy.Capital and Rising Star Venture Partners.

Healthy.Capital is an early-stage investment fund dedicated to healthcare startups, aiming to transform the healthcare industry through innovative technology.

Douwe Jippes, Co-founder and Managing Partner at Healthy.Capital, says, “The team at Guideways has a deep, personal understanding of the problem they are solving. They help companies to bring innovations to market faster and more successfully by significantly reducing the approval time and costs, fundamentally changing how medical devices are brought to market. This makes healthcare innovation more accessible and efficient, which perfectly aligns with our mission at Healthy.Capital to make healthcare affordable and accessible.”

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The company will use the funding to launch and scale its agentic AI platform, helping medical device firms achieve regulatory approval and accelerate patient access to lifesaving technologies. It will also support commercial launch, platform development, and expansion toward European MDR and reimbursement frameworks in 2026.

Founded by Sander Denissen and Alexander Habermeier, Guideways.ai helps medtech companies navigate regulatory, compliance and reimbursement complexity. Its AI-driven platform automates time-consuming approval processes, initially targeting US FDA pathways, reducing development costs and accelerating market entry for medical technologies.

Benjamin Sieters, Investment Director at Rising Star Venture Partners, says, “Guideways is a prime example of a company with the potential for fast and massive impact. By addressing barriers within the innovation pipeline, the company empowers health technology innovators to succeed and bring their solutions faster and more cost-effectively to a global market.”

We have seen first-hand how Guideways’ platform can reliably fast-track complicated and expensive steps in the critical route to regulatory approval, compliance and reimbursement. We are proud to back their mission to accelerate the availability of groundbreaking medical technologies,” concludes Sieters.

About Guideways.ai

Guideways.ai offers AI-powered solutions that help medtech companies navigate regulatory approval, compliance and reimbursement processes. Its intelligent agents automate time-consuming tasks reduce development costs and accelerate market entry, enabling innovators to bring lifesaving medical technologies to patients faster and more efficiently.